Product Details for: Monoclate, Monoclate-P

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
For Injection
Intravenous
500IU
Vial
351(a)
Monoclate, Monoclate-P
Disc
002
For Injection
Intravenous
1000IU
Vial
351(a)
Monoclate, Monoclate-P
Disc
003
For Injection
Intravenous
250IU
Vial
351(a)
Monoclate, Monoclate-P
Disc
004
For Injection
Intravenous
1500IU
Vial
351(a)
Monoclate, Monoclate-P
Disc
Proper Name
Antihemophilic Factor (Human)
BLA Number
103953
Applicant
CSL Behring LLC
Original Approval Date
May 14, 2003
Date of First Licensure
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